• PDTrials - Parkinson's Disease Clinical Trials
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Official Study Title: Efficacy  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. and tolerability of Ramelteon (Rozerem) in patients with REM behavior disorder and parkinsonism: A placebo,  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. controlled, double-blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. randomized pilot study
Sponsor: Takeda Pharmaceuticals North America
Clinicaltrials.gov ID:
Study ID: 07-028R

Summary

Sleep dysfunction impacts up to 90% of people with Parkinson’s disease (PD). People with PD experience a variety of sleep disorders including REM behavior disorder (RBD) in which they report acting out their dreams. RBD has negative consequences on the affected person’s and his or her bed partners’ quality of life mainly due to its impact on sleep quality and day time alertness. RBD also predisposes affected individuals and their bed partners to physical injuries.

There are no FDA approved treatments for RBD. Clonazepam is the most commonly used treatment but carries risks of daytime sedation, tolerance, and withdrawal symptoms. Ramelteon (Rozerem), an FDA approved drug for insomnia, could potentially be effective for the treatment of RBD.

This pilot project will investigate safety and efficacy of ramelteon for the treatment of RBD in participants with Parkinsonism. We plan to recruit 20 participants with RBD diagnosed based on the clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. interview and confirmed by polysomnographic (PSG) data. Participants will be randomized to receive either Ramelteon or placebo and will take the study medication before bed for a total of 8 weeks. Participants will wear an actigraph wristwatch everyday for a total of 12 weeks. The actigraph records their activity levels and light exposure.

Participants will complete a daily sleep log and bed partners complete a sleep log daily recording the frequency of the participant’s RBD events.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Sleep disturbances

Time Commitment

• Less than six months
• 12 weeks of participation; 5 visits

Eligibility

• Gender(s) Accepted: Either

Inclusion Criteria

• Diagnosis of Parkinsonism (PD, Multiple Systems Atrophy, Lewy Body Dementia)  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality.
• Presence of a Bed Partner/Caregiver who sleeps in the same room as the PD participant
• PD participant reports vivid dreams and/or acting out while dreaming (shouting, kicking, or punching)

Exclusion Criteria

• Use of drugs to help the participant fall asleep at night
• Hallucinations
• Diagnosis of Sleep Apnea
  
• Diagnosis of Periodic Limb Movement Disorder
  

Enrollment

Expected Enrollment: 20 (US)
Date Enrollment Began: Nov 01 2007
Last Updated Date: Aug 05 2008
Trial Post Date: Aug 05 2008
Website: http://www.parkinsons.northwestern.edu/research.html

Primary Contacts and Locations

Illinois

• Teresa Kuhta — Clinical Research  Clinical ResearchPatient-oriented research conducted with human participants (or on material of human origin such as tissues and specimens) for which an investigator directly interacts with human participants. This area of research includes: mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Coordinator
  Northwestern University
  t-kuhta@northwestern.edu
  Phone: (312) 503-1999
  Dr. Aleksandar Videnovic, MD, MSc (Site Investigator)
  710 N. Lake Shore Drive
  Chicago, IL 60611
  USA